The Recall Desk
ModerateFDA (Devices)·Z-2792-2020·Announced 2020-08-19

Brainlab Curve Navigation Stations Recalled for Incorrect Manufacturer Calibration

Brainlab AG is recalling 18 Curve navigation stations due to incorrect manufacturer calibration. The devices were distributed in the US and internationally.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any injuries, illnesses, or hospitalizations. The hazard is a technical calibration error without reported harm, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Brainlab AG is recalling 18 units of the BRAINLAB Curve navigation station, including Dual Navigation, Dual Display, and Single Display models. The recall is due to incorrect manufacturer calibration. The affected units are identified by specific model numbers (19901, 19901B, 19900, 19905) and serial numbers listed in the recall documentation.

The affected devices were distributed in the United States (California, Texas, Rhode Island) and in various countries including Armenia, Australia, Brazil, Bulgaria, Canada, Finland, France, Germany, Hong Kong, India, Israel, Italy, Japan, Mongolia, Morocco, and Spain.

Healthcare providers and consumers should stop using the affected devices and contact Brainlab AG for instructions on repair or replacement.

The recalled product

Product
BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905 UDI (GTIN) for Curve: 04056481138011
Manufacturer
Brainlab AG
Category
Medical Device — Surgical Navigation
Hazard
Affected units
18

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • CURVE 1.1 DUAL NAVIGATION STATION
  • Serial Numbers: 3911619001-19901
  • S/N of affected NDI Camera: P7-21527 1173019001-19901B
  • S/N of affected NDI Camera: P7-21173 1444519001-19901B
  • S/N of affected NDI Camera: P7-21183 1937319001-19901B
  • S/N of affected NDI Camera: P7-21325 2201419001-19901B
  • S/N of affected NDI Camera: P7-21324 2456219001-19901B
  • S/N of affected NDI Camera: P7-21382 3524219001-19901B
  • S/N of affected NDI Camera: P7-21414 5379420001-19901B
  • S/N of affected NDI Camera: P7-21830 5609520001-19901B
  • S/N of affected NDI Camera: P7-21892 6968320001-19901B
  • S/N of affected NDI Camera: P7-20390 4593720001-19901B
  • S/N of affected NDI Camera: P7-21655 7850820001-19901B
  • S/N of affected NDI Camera : P7-22083 6393920001-19901B
  • S/N of affected NDI Camera: P7-21895 3844314001-19901B
  • S/N of affected NDI Camera: P7-21449 CURVE DUAL DISPLAY NAVIGATION STATION
  • Serial Numbers: 0824912001-19900
  • S/N of affected NDI Camera: P7-21890 3894613001-19900
  • S/N of affected NDI Camera: P7-21780 4387415001-19900
  • S/N of affected NDI Camera:P7-07290 CURVE SINGLE DISPLAY NAVIGATION STATION

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 2 recalled by Brainlab AG under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Brainlab AG

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Same hazard · calibration error

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